Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-18.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2024 – 18 Apr 2024 | Human Drugs | Clean | |
| 30 Sep 2019 – 8 Oct 2019 | Human Drugs | 483 | On file |
| 27 May 2019 – 31 May 2019 | Human Drugs | Clean | |
| 26 Feb 2018 – 2 Mar 2018 | Human Drugs | 483 | View 483 → |
| 7 Nov 2016 – 11 Nov 2016 | Human Drugs | 483 | On file |
| 20 Jun 2014 – 25 Jun 2014 | Human Drugs | Clean | |
| 10 Feb 2012 | Not recorded | Clean | |
| 31 Oct 2008 | Not recorded | 483 | View 483 → |
| 21 Apr 2006 | Not recorded | Clean | |
| 25 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Mar 2018
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Saied A Asbagh
2 Mar 2018
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Saied A Asbagh
Investigators
FDA investigators tied to this site in the record.
John A Gonzalez1 insp.
Maxwell L Van Tassell1 insp.
Tonia F Bernard1 insp.
Saied A Asbagh1 insp.
Arsen Karapetyan1 insp.
Matt D Suedkamp1 insp.
Alice S Tsao1 insp.
Jose A Cruz Gonzalez1 insp.
Susan M Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Astellas Pharma Inc.'s 4 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat